The Use of Bellafill for Atrophic Acne Scar Correction in the Full Facial Area

Completed · Not applicable

Conditions studied: Atrophic Acne Scarring

In brief

This is an open-label, multicenter, prospective pilot study assessing the efficacy and safety of Bellafill for correction of distensible atrophic acne scars in the full facial area. All enrolled subjects will receive initial treatment with Bellafill, as well as touch-up treatments (if necessary to achieve optimal correction). Subjects will be evaluated at Screening (Month -1), Day 0 (Baseline) Month 1, Month 4, and Month 7.

Key facts

Study ID

NCT02642627

Run by

Suneva Medical, Inc.

People needed

42

Starts

2015-11-18

Expected to finish

2017-01-27

Last updated by the study team

2020-04-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatient, male or female subjects of any race, 21 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study.
• Negative response to the Bellafill Skin Test.
• Presence of ≥4 distensible atrophic acne scars (treatment scars) in in the facial area.
• Subject desires correction of his/her atrophic acne scarring.
• All Fitzpatrick skin types are eligible.
• Willing to withhold additional aesthetic therapies to the proposed treatment area (e.g., other soft tissue fillers such as hyaluronic acid, and/or any resurfacing procedures (as described in Protocol Section 5.4) for the duration of the study.
• Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
• Sign an IRB-approved Informed Consent Form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) Form prior to any study-related procedures being performed.

You may not qualify if…

• Female subjects that are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
• Undergone facial treatments with any prohibited treatment/procedures and/or use of any other prohibited treatment/procedure within certain time periods as listed in Protocol Section 5.4.
• Excisional facial surgery (such as Blepharoplasty, Face Lift, Rhinoplasty) of the face less than 6 months prior to study enrollment or plans for facial surgery during the study.
• History of bleeding disorders.
• Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to the proposed treatment or require interfering topical, systemic or surgical therapy.
• Recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound or clinically significant acne in the proposed treatment areas. Clinically significant acne is defined as a patient whom has ≥3 active inflammatory acne lesions in the treatment areas.
• History of systemic granulomatous diseases active or inactive (e.g., Sarcoid, Wegeners, TB) or connective tissue diseases (e.g., lupus, dermatomyositis).
• Hypertrophic acne scars, any evidence of keloid scarring in the treatment area.
• Known hypersensitivity or previous allergic reaction to any of the components of the study device (including lidocaine or any amide-based anesthetic), or has a history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges, and collagen-based sutures.
• Undergone or be planning to undergo desensitization injections to meat products.
• Unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
• Evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
• Use of an investigational device, biologic or drug in the past 30 days, or be currently participating in an experimental drug, biologic or device trial.
• Exhibits additional physical attributes which prevent the assessment or treatment of the atrophic scars, as judged by the Investigator, such as excessive hair, traumatic or surgical scars, excessive hyperpigmentation in the treatment area, etc.
• Has a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
• An employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.

Where it is running

• Call Suneva for Info — Houston, Texas, United States

Full record on ClinicalTrials.gov

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